Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer

NCT03180528 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-40947NCI-2017-00981SKIN0037
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 2 trial studies how well remetinostat works in treating patients with skin basal cell cancer. Remetinostat may slow the growth of basal cell cancer cells.

Conditions

Skin Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall response is defined as achieving either a complete response (CR) or a partial response (PR). Response is based on the Response Evaluation Criteria in Solid Tumors (RECIST), as follows. * CR = tumor lesion becomes undetectable * PR = ≥30% decrease in total tumor diameter * Overall response (OR) = CR+PR * Stable Disease (SD) = decrease in total tumor diameter is \>0% and \<30% * Progressive Disease (PD) = increase in total tumor diameter Exact binomial 90% confidence intervals (90%) will be computed for OR. The data are reported accord to the per protocol analysis, ie, including lesions for subjects who were \<70% compliant with drug treatment. For subjects who were compliant but dropped out, data from their last study visit will be used if they contribute a biopsy. The analysis population will include the participants who have provided pre-treatment and post-treatment biopsies. The outcome is reported as the percent of tumor lesions that achieve OR, with 90% CI.

  At 6 weeks

Secondary Outcomes (3)

• Number of Participants With a Decrease in Expression of the Hedgehog Biomarker Gene GLI1

  6 weeks

• Adverse Events Contributing to Treatment Discontinuation or Interruption

  6 weeks

• Participants Who Discontinued Treatment or Had Treatment Interruption

  6 weeks

Study Arms (1)

Treatment (remetinostat)

EXPERIMENTAL

Patients receive topical remetinostat 1% gel applied TID directly to the lesion, for 6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Remetinostat

Interventions

Remetinostat DRUG

Applied topically under bandage occlusion

Also known as: suberohydroxamic acid phenyl ester (SHAPE); SHAPE Gel; SHP 141; and 4 [[8 (hydroxyamino) 1,8 dioxooctyl]oxy] benzoic acid methyl ester

Treatment (remetinostat)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have at least one BCC lesion \> 1 cm (BCC \> 5 mm) in non-cosmetically sensitive site(s)
• Must be willing to apply the topical remetinostat 3 times daily for 6 weeks
• For women of child bearing potential, a negative urine pregnancy test
• Women of child bearing potential are expected to use an effective method of birth control while participating in the study and for 1 month after applying the last dose
• For male subjects with female partners of childbearing potential, agreement to use adequate contraception while participating in the study and for 1 month after applying the last dose
• Has signed and dated the current Institutional Review Board (IRB) approved informed consent document

You may not qualify if:

• Taking any medication known to interact with histone deacetylase (HDAC) inhibitors, such as valproate or anticoagulants
• Taking any medication known to affect hedgehog (HH) signaling pathway such as itraconazole
• Within the past 6 months, has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically, these include the topical use to the study tumors of:
• Glucocorticoids
• Retinoids either systemically or topically (eg, etretinate, isotretinoin, tazarotene, tretinoin, adapalene)
• Alpha hydroxy acids (eg, glycolic acid, lactic acid) to \> 5% of the skin
• fluorouracil or imiquimod and/or
• Itraconazole
• Has received treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling, within 60 days to starting study medication
• Currently receiving systemic medications that could affect BCC tumors (eg, oral retinoids) or might interact with remetinostat
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, recurrent seizure history or psychiatric illness/social situations that would limit compliance with study requirements
• Moderate to severe immunosuppression due to disease or medication
• Known or previous hypersensitivity to histone deacetylase inhibitor (HDACi)
• History of congestive heart failure; cardiac arrhythmias; or other findings of ventricular dysfunction
• History of current evidence of malabsorption or liver disease

Sponsors & Collaborators

• Kavita Sarin: lead
• Medivir: collaborator
• National Institutes of Health (NIH): collaborator
• American Skin Association: collaborator

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

remetinostat

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Results Point of Contact

• Title: Kavita Yang Sarin
• Organization: Stanford University

ksarin@stanford.edu

(650) 723-6316

Study Officials

• Kavita Sarin

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: July 7, 2018
• Primary Completion: July 7, 2020
• Study Completion: December 31, 2020
• Last Updated: June 8, 2021
• Results First Posted: January 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)